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FDA 510(k)

Vanquish Water Vapor Ablation Device

K-Number: K252388 · 2025-11-26

ApplicantFrancis Medical, Inc.
Decision Date2025-11-26
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vanquish Water Vapor Ablation Device is the device name listed in this FDA 510(k) record. The listed applicant is Francis Medical, Inc.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K252388. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vanquish Water Vapor Ablation Device?

Vanquish Water Vapor Ablation Device is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Francis Medical, Inc.. The 510(k) number is K252388.

When did Vanquish Water Vapor Ablation Device receive FDA 510(k) clearance?

Vanquish Water Vapor Ablation Device received FDA 510(k) clearance on 2025-11-26, under 510(k) number K252388.

Who is the listed applicant for Vanquish Water Vapor Ablation Device?

The FDA 510(k) record lists Francis Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vanquish Water Vapor Ablation Device?

The FDA product code for Vanquish Water Vapor Ablation Device is KNS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07455058Water Vapor Ablation for Prostate Cancer: Long-Term RegistryRECRUITINGNCT07652164Water Vapor Ablation for Grade Group 3 Prostate CancerNOT_YET_RECRUITINGNCT05683691Water Vapor Ablation for Localized Intermediate Risk Prostate CancerACTIVE_NOT_RECRUITINGNCT07578428Comparative Outcomes of Rezūm Versus EchoLaser for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe.NOT_YET_RECRUITING

Related Devices (Code: KNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260962SphincterotomeTaewoong Medical Co., Ltd.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems CorporationK251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook MedicalK251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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